US8257308B2 - Drug delivery device with a module for preventing fibrillation downstream of its reservoir - Google Patents
Drug delivery device with a module for preventing fibrillation downstream of its reservoir Download PDFInfo
- Publication number
- US8257308B2 US8257308B2 US13/059,516 US200913059516A US8257308B2 US 8257308 B2 US8257308 B2 US 8257308B2 US 200913059516 A US200913059516 A US 200913059516A US 8257308 B2 US8257308 B2 US 8257308B2
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- United States
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- delivery device
- drug delivery
- drug
- porous membrane
- reservoir
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/36—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests with means for eliminating or preventing injection or infusion of air into body
- A61M5/38—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests with means for eliminating or preventing injection or infusion of air into body using hydrophilic or hydrophobic filters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/165—Filtering accessories, e.g. blood filters, filters for infusion liquids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/75—General characteristics of the apparatus with filters
- A61M2205/7527—General characteristics of the apparatus with filters liquophilic, hydrophilic
Definitions
- the present invention relates to a drug delivery device, in particular for the delivery of drugs comprising molecules tending to spontaneously form nucleation seeds leading to fibrils and aggregates, comprising a drug reservoir having a reservoir outlet connected to a device outlet, adapted to deliver a drug fluid to a patient's body, through a pathway including a fluid flow controlling system.
- the delivery device according to the invention is particularly well adapted for the delivery of insulin.
- the neutral insulin solution introduced as Actrapid nearly 40 years ago can be stored for several years at room temperature without significant change or loss of biological activity.
- Insulin fibril formation involves the dissociation of native associated states (hexamer, tetramer, and dimer) to give native monomer. Therefore, by stabilizing the hexamer insulin with two extra Zn 2+ , the formation of the intermediate which then oligomerizes to form transient soluble oligomers that lead to a fibril nucleus will be strongly reduced resulting in an improved stability, i.e. a longer fibrillation lag time.
- a continuous exposure to condition simulating insulin infusion is expected to accelerate the fibrillation process.
- the solution may reside in the reservoir for several days, which will promote fibril seeds formation, even with the above-mentioned stabilized formulations. If the amount of these fibrils is not an issue in term of insulin stability, the presence of these seeds represents a real problem for the functionality of the infusion system when the solution enters downstream of the fluidic path.
- seeding a solution with preformed insulin aggregates markedly accelerates the rate of aggregate, which can alter some functionality of the device downstream of the reservoir such as the leaktightness of the system or the fluidic resistance of a channel or also modify the efficacy of the insulin itself.
- a principal object of the present invention is to offset the drawbacks of the prior art mentioned above by avoiding the nucleation seeds to enter downstream of the reservoir, i.e. where the environmental condition can potentially favor fibrillation.
- embodiments of the present invention include in particular a drug delivery device as disclosed above, characterised by the fact that the device pathway further includes a filtration module comprising a porous membrane which is adapted to absorb nucleation seeds.
- the filtration module is arranged at the reservoir outlet and may include a porous membrane.
- the device when it is intended for delivery of insulin or any other drug having similar physicochemical properties, it may be further characterised by the fact that, either it has a mean pore size that is approximately X times the mean diameter of said nucleation seeds, where X is equal to 0.9, or smaller, in order to retain said nucleation seeds essentially by size screening, or it has a mean pore size that is approximately X times the mean diameter of said nucleus seeds, where X is equal to 2, or larger, in order to retain said nucleation seeds essentially by adsorption on the surface of the pores.
- the filtration module may exhibit hydrophobic surface properties in the second case.
- the principle of such a filtration module may be based on the hydrophobic nature of the nucleation seeds: in fact, the blockage of the seeds may be ensured by their adsorption on the filtration module surface.
- the filtration module may exhibit hydrophilic surface properties, at least at its external surface arranged on the reservoir side, so as to prevent air bubbles to travel in the pathway, outside the reservoir.
- the filtration module may comprise a porous membrane which may have a mean pore size in the range between 4 and 25 nm, for size screening or, alternately in the range between 50 and 1000 nm for filtration by adsorption.
- the membrane may be made of a material taken from the group comprising: Polypropylene (PP), Polystyrene (PS), High impact polystyrene (HIPS), Acrylonitrile butadiene styrene (ABS), Polyethylene terephthalate (PET), Polyester (PES), Polyamides (PA) (Nylons), Poly(vinyl chloride) (PVC), Polyurethanes (PU), Polycarbonate (PC), Polyvinylidene chloride (PVDC), Polyethylene (PE), Polycarbonate/Acrylonitrile Butadiene Styrene (PC/ABS), Polymethyl methacrylate (PMMA), Polytetrafluoroethylene (PTFE), Polyetheretherketone (PEEK), Polyetherimide (PEI), Phenolics (PF), Urea-formaldehyde (UF), Melamine formaldehyde (MF), Polylactic acid and Plastarch material.
- PP Polypropylene
- PS Polystyrene
- FIG. 1 shows a schematic diagram of a drug delivery device according to the present invention
- FIG. 2 shows a simplified exploded view of a preferred exemplary embodiment of a drug delivery device according to the present invention
- FIG. 3 shows an experimental diagram on which the advantages of the present invention are made apparent.
- FIG. 1 shows a schematic diagram illustrating the principle of a drug delivery device according to the present invention.
- a drug delivery device 1 arranged for delivering drug from a drug reservoir 2 to a patient's body (illustrated by arrow 3 on FIG. 1 ) by means of a flow controlling system such as a pump 4 forcing the drug to circulate through a pathway including a tubing 5 .
- the device according to the invention further includes a filtration module 6 designed for preventing fibril seeds formed in the reservoir to enter downstream in the pathway, where a potential fibril agglomeration may present a real issue for the delivery device or for the drug.
- the filtration module may comprise a filter or filtering membrane located in the fluid pathway, downstream of the reservoir outlet, and which preferably has a surface oriented transversely in the pathway and the area of which could be in the range approximately between 0.25 and 5 cm 2 as far as micro-devices are concerned.
- the filter could be arranged to block the nucleation seeds by size exclusion with pore sizes comprised between 10 and 20 nm, for instance, which has been reported to correspond substantially to the typical diameter of an insulin fibril seed.
- pore sizes comprised between 10 and 20 nm, for instance, which has been reported to correspond substantially to the typical diameter of an insulin fibril seed.
- the use of such pore sizes may represent an important drawback for the delivery device by introducing a high fluidic resistance in the pathway which may interfere with the flow characteristics of the device during its implementation.
- a filter having a pore size of 20 nm exhibits a fluidic resistance which is 120 times higher than a filter having a pore size of 220 nm, which may allow ensuring an aseptic drug infusion through filtration, in principle.
- the membrane may comprise pores of larger sizes so as to perform a blockage of the nucleation seeds by their adsorption on the filtration module surface by the way of hydrophobic interaction.
- the filtering membrane may preferably have a surface with good hydrophobic properties to promote nucleation seeds adsorption and an area large enough to prevent surface nucleation seed saturation.
- the porosity of the membrane should be chosen so as to allow an effective surface contact to promote the nucleation seed adsorption.
- the filtering membrane may have a mean pore size that is either approximately X times the mean diameter of the nucleation seeds, where X is equal to 0.9, or smaller, in order to retain the nucleation seeds essentially by size screening, or approximately X times the mean diameter of said nucleus seeds, where X is equal to 2, or larger, in order to retain said nucleation seeds essentially by adsorption on the surface of the pores.
- the porous membrane may have a mean pore size in the range between 4 and 25 nm, for size screening or, alternately in the range between 50 and 1000 nm for filtration by adsorption.
- a material such as micro-structured plastic for instance taken from the group comprising: Polypropylene (PP), Polystyrene (PS), High impact polystyrene (HIPS), Acrylonitrile butadiene styrene (ABS), Polyethylene terephthalate (PET), Polyester (PES), Polyamides (PA) (Nylons), Poly(vinyl chloride) (PVC), Polyurethanes (PU), Polycarbonate (PC), Polyvinylidene chloride (PVDC), Polyethylene (PE), Polycarbonate/Acrylonitrile Butadiene Styrene (PC/ABS), Polymethyl methacrylate (PMMA), Polytetrafluoroethylene (PTFE), Polyetheretherketone (PEEK), Polyetherimide (PEI), Phenolics (PF), Urea-formaldehyde (UF), Melamine formaldehyde (MF), Polylactic acid and Plastarch material.
- the membrane may preferably exhibit a material such as micro
- FIG. 2 shows a simplified exploded view of a preferred exemplary embodiment of a drug delivery device according to the present invention.
- the device 100 comprises a reservoir 102 and a pump cell 104 , while a porous membrane 106 is arranged at the outlet 107 of the reservoir in order to protect the pump cell and the patient from the risk of fibril agglomeration.
- the membrane may be arranged at any place along the fluid pathway.
- the reservoir outlet is preferred as far as an arrangement of the membrane at this location allows protecting the pump cell from occlusion together with the other parts of the delivery device.
- a filter may be provided to prevent air bubbles going out from the reservoir downstream in the pathway.
- the one skilled in the art will encounter no particular difficulty to optimize one single membrane to filter both air bubbles and nucleation seeds or, alternately, to use two distinct membranes, according to his needs and without departing from the scope of the invention.
- the filtration module may exhibit hydrophilic surface properties, at least at its external surface arranged on the reservoir side, so as to prevent air bubbles to travel in the pathway, outside the reservoir.
- FIG. 3 shows a diagram of the results of comparative experimentations conducted on the basis of the device of FIG. 2 .
- this diagram shows the lag time as a function of incubation duration (14 and 30 days) of insulin solution of the same batch incubated in the pump reservoir (described in connection with FIG. 2 ) at 37° C. under orbital agitation.
- the bar with horizontal strips represent the data of the solution that passed through the filter membrane before analysis, and the bar with the diagonal strips represent the same solution stored in the reservoir and not processed though the filter before analysis.
- the represented values are the average of 8 measurements and the error bars are the standard deviation.
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- Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Heart & Thoracic Surgery (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Public Health (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Anesthesiology (AREA)
- Engineering & Computer Science (AREA)
- Vascular Medicine (AREA)
- Emergency Medicine (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Separation Using Semi-Permeable Membranes (AREA)
- External Artificial Organs (AREA)
Abstract
Description
Claims (18)
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP08162871A EP2158927A1 (en) | 2008-08-25 | 2008-08-25 | Drug delivery device with a module for preventing fibrillation downstream of its reservoir |
EP08162871 | 2008-08-25 | ||
EP08162871.1 | 2008-08-25 | ||
PCT/IB2009/053128 WO2010023567A1 (en) | 2008-08-25 | 2009-07-20 | Drug delivery device with a module for preventing fibrillation downstream of its reservoir |
Publications (2)
Publication Number | Publication Date |
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US20110144585A1 US20110144585A1 (en) | 2011-06-16 |
US8257308B2 true US8257308B2 (en) | 2012-09-04 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US13/059,516 Active US8257308B2 (en) | 2008-08-25 | 2009-07-20 | Drug delivery device with a module for preventing fibrillation downstream of its reservoir |
Country Status (8)
Country | Link |
---|---|
US (1) | US8257308B2 (en) |
EP (2) | EP2158927A1 (en) |
JP (1) | JP5647123B2 (en) |
CN (1) | CN102123750B (en) |
AU (1) | AU2009286442B2 (en) |
CA (1) | CA2726839A1 (en) |
ES (1) | ES2780148T3 (en) |
WO (1) | WO2010023567A1 (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20160038681A1 (en) * | 2014-02-26 | 2016-02-11 | Powder Pharmaceuticals Incorporated | Devices and methods for delivering particles |
Families Citing this family (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2556815A1 (en) * | 2011-08-10 | 2013-02-13 | Debiotech S.A. | Container for storing a drug such as insulin |
US20140224829A1 (en) | 2011-09-21 | 2014-08-14 | Bayer Medical Care Inc. | Continuous Multi-Fluid Delivery System and Method |
US9074972B2 (en) | 2012-05-16 | 2015-07-07 | Dionex Corporation | Surrogate addition device and a method of analyte concentration |
EP3185931A1 (en) * | 2014-08-26 | 2017-07-05 | Debiotech S.A. | Detection of an infusion anomaly |
AU2016205275B2 (en) | 2015-01-09 | 2020-11-12 | Bayer Healthcare Llc | Multiple fluid delivery system with multi-use disposable set and features thereof |
US10821156B2 (en) | 2016-04-12 | 2020-11-03 | Cell and Molecular Tissue Engineering, LLC | Systems, methods and products for minimizing tissue reactions and tissue injury at an infusion site |
CA3060234A1 (en) * | 2018-11-20 | 2020-05-20 | Becton, Dickinson And Company | Fluid path channel and adsorbent |
Citations (8)
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US4642098A (en) * | 1981-06-29 | 1987-02-10 | Valleylab, Inc. | IV system and controller and combination IV filter and pump assembly for use therein and method |
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WO2002085428A2 (en) | 2001-04-19 | 2002-10-31 | Microsolutions, Inc. | Implantable osmotic pump |
US20020193732A1 (en) | 2001-06-19 | 2002-12-19 | Wendy Naimark | Method and apparatus to modify a fluid using a selectively permeable membrane |
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- 2009-07-20 CN CN200980132347.9A patent/CN102123750B/en not_active Expired - Fee Related
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US20160038681A1 (en) * | 2014-02-26 | 2016-02-11 | Powder Pharmaceuticals Incorporated | Devices and methods for delivering particles |
US9370622B2 (en) * | 2014-02-26 | 2016-06-21 | Powder Pharmaceuticals Incorporated | Devices and methods for delivering particles |
US10071204B2 (en) | 2014-02-26 | 2018-09-11 | Powder Pharmaceuticals Incorporated | Devices and methods for delivering particles |
US10384012B2 (en) | 2014-02-26 | 2019-08-20 | Powder Pharmaceuticals Incorporated | Devices and methods for delivering particles |
US10384011B2 (en) | 2014-02-26 | 2019-08-20 | Powder Pharmaceuticals Incorporated | Devices and methods for delivering particles |
Also Published As
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AU2009286442B2 (en) | 2014-04-03 |
ES2780148T3 (en) | 2020-08-24 |
JP2012500697A (en) | 2012-01-12 |
US20110144585A1 (en) | 2011-06-16 |
AU2009286442A1 (en) | 2010-03-04 |
CN102123750A (en) | 2011-07-13 |
WO2010023567A1 (en) | 2010-03-04 |
EP2331168B1 (en) | 2020-02-19 |
JP5647123B2 (en) | 2014-12-24 |
CA2726839A1 (en) | 2010-03-04 |
EP2158927A1 (en) | 2010-03-03 |
CN102123750B (en) | 2014-08-13 |
EP2331168A1 (en) | 2011-06-15 |
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